Kornimate/medical-research-clean huggingface dataset:
clinical trial of uterine artery embolization for uterine leiomyoma

Conditions: Leiomyoma

Summary: the efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. the purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of symptomatic uterine leiomyoma exclusion criteria: * pregnancy * iodine agent allergy * patient refuse to take part in this trial * tumour size is less than 3cm or beyond 10cm * with endometriosis * with malignant diseases * with abnormal coagulation function which can't restore * with acute inflammatory diseases or acute episode of chronic inflammatory diseases * with severe heart, lung, liver and kidney, et al. organ diseases.

Keywords: uterine artery embolization leiomyoma myomectomy hysterectomy pregnancy complication ovarian function quality of life
pcv13 effectiveness study against hospitalised vt pneumococcal cap in adults 60 years and older

Conditions: Community Acquired Pneumonia (CAP)

Summary: low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with cap at participating sites.

pcv13 efficacy for the prevention of vaccine-type community-acquired pneumonia (vt-cap) and invasive pneumococcal disease (ipd) was established in the community-acquired pneumonia immunization trial in adults (capita) aged 65 and older. however, there are still few available real-life effectiveness estimates in adults. the aim of this study is to evaluate the pcv13 vaccine effectiveness (ve) against hospitalised vt-pneumococcal cap among adults aged ≥60 years in the region of madrid (spain). determination of the effectiveness of pcv13 to prevent hospitalised vaccine-type (vt)-pneumococcal cap among adults aged ≥60 years in madrid will be evaluated using a test-negative design study, overall and among immunocompetent persons only.

Eligibility criteria:
inclusion criteria: 1. age ≥60 years. 2. evidence of pneumonia within first 48 hours of hospital admission 3. evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: 1. any patient who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at current hospital, another transferring hospital, or a combination of these). 2. previously enrolled subjects readmitted ≤14 days after discharge for their study qualifying admission. 3. at the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.
the effect of interscalene block on intracranial pressure

Conditions: Brachial Plexus Block; Intracranial Pressure Increase

Summary: the study aims to show the effects of interscalene brachial plexus (isbp) block on intracranial pressure by measuring optic nerve sheath diameter (onsd) and internal vein collapsibility index (ijv-ci).

40 is the targeted number of patients who are going to have humerus fracture or opened rotator-cuff surgery. single shot-isbp block with 25 ml local anesthetic will be performed as anesthetic approach for surgery to all participants. intraoperative onsd and ijv-ci measurements will be performed before the isbp block, 20 minutes and 60 minutes after the block. hypothesis; external drug-volume effect on internal jugular vein causes decreasing maximum diameter of internal jugular vein (dmax), venous return from cranium to heart decreases, intracranial pressure can increase.

Eligibility criteria:
inclusion criteria: * patients who had elective humeral fracture and open rotator-cuff surgery, * patients aged 18-85 years, * patients have asa i-ii anesthesia risk according to the american society of anesthesiologists (asa) risk classification, * patients that gave consent for participation in the study will be included. exclusion criteria: * patients who do not give consent to the study, * patients with infection and open wounds in the area of skin puncture and eyelids, * patients have any history of intracranial pathology, * patients have nerve blockade contraindications such as coagulation disorder and antithrombotic-anticoagulant use, * patients have a history of allergy to one of the study drugs, * patients have a body mass index over 35 kg/m2, * patients with contralateral pneumothorax, * patients with severe respiratory distress, * patients with uncontrolled hypertension, * patients with acute or chronic eye disease, * patients with previous eye surgery, * patients using a beta-blocker known to increase intraocular pressure, * patients using calcium channel blockers, statins and nitrates, * patients in need of intraoperative sedation, * patients who develope any complications (hoarseness, horner's syndrome, respiratory distress, local anesthetic toxicity) due to isbp block will be excluded from the study.

Keywords: interscalene brachial plexus block intracranial pressure optic nerve sheath diameter internal jugular vein collapsibility index
study of tinengotinib vs. physician's choice a treatment of subjects with fgfr-altered in cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: this study is a phase iii, randomized, controlled, global multicenter study to evaluate the efficacy and safety of oral tinengotinib versus physician's choice in subjects with fibroblast growth factor receptor (fgfr)-altered, chemotherapy- and fgfr inhibitor-refractory/relapsed cholangiocarcinoma

approximately 200 subjects will be enrolled. eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg qd, tinengotinib 10 mg qd or physician's choice in part a; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended part b dose or selected dose or physician's choice in part b.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age at the time of signing the informed consent form (icf). 2. histologically or cytologically confirmed cca/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease. 3. documentation of fgfr2 fusion/rearrangement gene status 4. subjects must have received at least one line of prior chemotherapy and exactly one fda approved fgfr inhibitor. exclusion criteria: 1. prior receipt of two or more fgfr inhibitors, either approved or investigational drugs. 2. subjects with known brain or central nervous system (cns) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. subjects with asymptomatic brain/cns metastases or treated brain/cns metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment. 3. subjects with a known concurrent malignancy that is progressing or requires active treatment. exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy. 4. subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (aes) of prior therapy. 5. concurrent anticancer therapy including chemo-, immune-, or radiotherapy. hormone therapy may be allowed with sponsor approval. 6. subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from aes of prior therapy. 7. subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm hg systolic and/or ≥ 90 mm hg diastolic despite adequate treatment with antihypertensive medications at screening)

Keywords: refractory/relapsed cholangiocarcinoma
providing an optimized and empowered pregnancy for you (poppy) aim 3: randomized controlled trial

Conditions: Pregnancy Complications; Maternal Distress; Adverse Birth Outcomes; Infant Conditions

Summary: the pᵌoppy study is designed to support the american heart association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. the p3oppy project is one of five projects within the american heart association p3 equate network. the overarching goal of the p3 equate american heart association health equity research network (hern) is to promote equity in maternal and infant health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for black and under-served populations. collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. in this trial, 400 non-hispanic black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.

the aim of this trial is to assess whether an existing digital heath intervention (dhi) and/or a community health worker (chw) intervention will reduce adverse maternal and perinatal outcomes. a 2 x 2 factorial randomized controlled trial of non-hispanic black (nhb) patients living in high area deprivation index (adi) communities will be conducted. participants (n=400) will be randomized 1:1:1:1 to one of 4 arms: 1) standard prenatal care (pnc) alone, or 2) standard pnc plus dhi, or 3) standard pnc plus chw, or 4) standard pnc, plus dhi and chw. the pᵌoppy study is designed to support the american heart association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. the promise of digital health and community health worker engagement makes pᵌoppy interventions potentially transformative, sustainable, and scalable for non-hispanic black mothers and their infants from under-served communities in alabama and beyond.

Eligibility criteria:
inclusion criteria: * self identifies as non-hispanic black * between 16-49 years old * pregnant individuals between 8⁰ - 22⁶ weeks gestational age * live singleton or dichorionic twin gestation * dating sonogram at \<23 weeks gestation, * area deprivation index (adi) national 4th or 5th quintile * planning to deliver at uab hospital * speaks and writes in english * no indication for delivery at the time of enrollment exclusion criteria: * declines randomization * speaks or writes in languages other than english * currently incarcerated * fetal demise diagnosed prior to enrollment * known major structural chromosomal abnormalities prior to enrollment * participated in poppy pilot

Keywords: pregnancy outcomes health inequities
rapid learning for lung cancer

Conditions: Lung Cancer

Summary: a retrospective, data mining project that re-uses routine patient care data for decision support systems.

by installing tools that extract clinical data from electronic health records and image data from the picture archiving and communication system, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.

Eligibility criteria:
inclusion criteria: - patients notes as suffering from lung cancer in at least one clinical data source.

Keywords: retrospective lung cancer
spontaneous atrioventricular conduction preservation

Conditions: Patients With Pacemaker With Conduction Problems

Summary: the aims of this study are to assess the clinical benefits resulting from safer by comparison with standard dual chamber programming (ddd) with a long atrioventricular (av) delay. the benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (anp/bnp) measurements.


Eligibility criteria:
inclusion criteria: * any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation3) may be included in the study. exclusion criteria: the patients presenting with one or more of the following characteristics cannot be included: permanent complete av block * permanent atrial and/or ventricular arrhythmias * already implanted with a cardioverter-defibrillator (icd) * likely to have a cardiac surgery in the next six months, mainly for: * severe coronary artery disease * severe valvular disease * av node ablation * refuses to sign an consent form after having received the appropriate information * refuses to co-operate * not able to understand the study objectives and protocol * not available for scheduled follow-up * with a life expectancy less than one year * already included into another clinical study competing with the objectives of the can-save r study * \<18 years old

Keywords: av conduction atrial fibrillation
comparison of programmable and non-programmable csf shunts among adult hydrocephalus patients with different etiologies

Conditions: Hydrocephalus; Ventriculoperitoneal Shunt Malfunction

Summary: programmable valve (pv) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. this study is to compare the overall revision rate, revision cause, and revision-free survival between pv and non-programmable valve (npv) in adult patients with different hydrocephalus etiologies.

relatively high revision rates up to 32% of csf shunting operations remained an unsolved problem for neurosurgeons. the cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. programmable valve (pv) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. this study is to compare the overall revision rate, revision cause, and revision-free survival between pv and non-programmable valve (npv) in adult patients with different hydrocephalus etiologies. the investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular csf shunt operations conducted at a single institution in northern taiwan from january 2017 to december 2017. patients included in the study were followed up for at least five years. statistical tests including independent t-test, chi-square test and fisher's exact test were used for comparative analysis, and kaplan-meier curve using log-rank test was performed to compare the revision-free survival between the pv and npv groups

Eligibility criteria:
inclusion criteria: * received shunting operations at chang gung medical foundation, linkou branch from 2017/01/01\~2017/12/31 exclusion criteria: * patients who received index ventricular csf shunt at other hospitals, * patients who received index ventricular csf shunt before january 1st 2017, * patients who were younger than 18

Keywords: hydrocephalus programmable shunt long-term outcome
lcar-b38m cells in treating relapsed/refractory (r/r) multiple myeloma

Conditions: Refractory or Relapsed Multiple Myeloma

Summary: this is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of lcar-b38m car-t cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r mm).

multiple myeloma (mm) is a usually incurable malignancy of plasma cells. current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse and die, an clear unmet clinical needs. as early as mid-2014, the investigators have started to develop a series of proprietary car-t products to target b cell maturation antigen (bcma), a cell surface molecule which the investigator believes to be a desirable target antigen for multiple myeloma. all pre-clinical data and cmc data for lcar-b38m car-t cell technology has been established by mid-2015 and a phase i proof-of-concept clinical trial has been planned since then.

Eligibility criteria:
inclusion criteria: * patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated imwg criteria. * patients with refractory multiple myeloma. clear bcma expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry. * refractory disease：1) at least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors. * relapse criteria in nccn clinical practice guidelines in oncology: multiple myeloma (2016.v2) exclusion criteria: * women of child-bearing potential or who are pregnant or breastfeeding. * have any active and uncontrolled infection: hepatitis b, hepatitis c, hiv, or other fatal viral and bacterial infection. * systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen. * patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder. * patients with cns metastases or symptomatic cns involvement (including cranial neuropathies or mass lesions and spinal cord compression). * history of allogeneic stem cell transplantation. have active acute or chronic graft-versus-host-disease (gvhd), or require immunosuppressant medications for gvhd, within 6 months of enrollment. * patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.

Keywords: multiple myeloma bcma car-t
treximet (sumatriptan/naproxen sodium), formerly known as trexima, for menstrual migraine in women with dysmenorrhea

Conditions: Migraine Disorders

Summary: this study was designed to determine efficacy of trexima compared to placebo for the treatment of a menstrual migraine.

a randomized, double-blind, single migraine attack, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and tolerability of trexima\* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea. (treximet was formerly known as trexima)

Eligibility criteria:
inclusion criteria: * at least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month. * typically experiences moderate to severe migraine pain preceded by a mild pain phase. * differentiate between mild migraine pain and other headache types. * women of childbearing potential must be on adequate contraception. exclusion criteria: * pregnant and/or nursing mother. * history of cardiovascular disease. * uncontrolled hypertension. * basilar or hemiplegic migraine. * history of stroke or transient ischemic attacks (tia). * history of epilepsy or treated with anti-epileptics within past 5 years. * impaired hepatic or renal function. * history of gastrointestinal bleeding or ulceration. * allergy or hypersensitivity to aspirin or any other nsaid. * allergy or hypersensitivity to triptans. * participated in an investigational drug trial in the previous 4 weeks.

Keywords: menstrual migraine headache early intervention dysmenorrhea
transcranial magnetic stimulation and perioperative neurocognitive disorders

Conditions: Postoperative Cognitive Dysfunction; Repetitive Transcranial Magnetic Stimulation

Summary: to investigate the impact of rtms on the incidence of perioperative neurocognitive disorders in patients after after cardiac surgerysurgery. to explore the underlying mechanisms behind the efficacy.

there is a relatively high incidence of perioperative neurocognitive disorders（pnd） after surgeries, and the incidence is even higher in the geriatric population undergoing cardiac surgery. nevertheless, there remains no effective medication or intervention been approved in pnd. it has been shown that brain stimulation can improve cognitive function in mild cognitively impaired patients. however, the effects on cognitive function in pnd remain uninvestigated.

Eligibility criteria:
inclusion criteria: * 1. age 18 years or older. * 2. asa class i - iii, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery). * 3. sign the informed consent. * 4. able to complete follow-up visits. exclusion criteria: * 1. a history of psychopathology and/or taking medication. * 2. previous history of neurological disease. * 3. severe organic diseases. * 4. rtms contraindications (such as a history of epileptic seizures, metal implants near the head). * 5. having delirium, assessed by cam, before surgery. * 6. participating in other clinical studies at the time of screening. * 7. having a cardiopulmonary arrest and cardiopulmonary resuscitation. * 8. having short-term second operation.
behavioral memory modulation in nicotine addiction

Conditions: Nicotine Use Disorder

Summary: the purpose of the study is to see if a behavioral intervention known as retrieval-extinction training (ret) might affect craving in response to nicotine cues (e.g., pictures, videos and objects) and smoking behavior in men and women who smoke cigarettes.

in a recently published nida-funded study, the investigators found that lasting reductions in craving and smoking could be achieved with a brief behavioral intervention designed to alter memory processes underlying smoking-related nicotine addiction. the proposed project will replicate and extend these findings by 1) increasing the dose of intervention so as to bolster the observed treatment effects, 2) employing brain imaging methods to identify patterns of brain activity uniquely associated with the intervention and potentially predictive of treatment outcome, 3) extending follow-up period to more completely document the long-term effects of the intervention. positive findings from this study could lead to the development of brief therapy that will not only improve treatment outcomes for smokers, but also be used in the treatment other substance use disorders and frequently co-occurring comorbidities such as ptsd.

Eligibility criteria:
inclusion criteria 1. healthy men and women, ages 25 to 65, who have smoked at least 10 cigarettes per day for at least 3 years. 2. participants must live within a 50-mile radius of the research facility and have reliable transportation. 3. participants must be willing to abstain from smoking starting the night before the baseline visit, and starting the night before visit 1 and remain abstinent for four consecutive days. 4. participants must agree to forego any other medication or behavioral treatment for smoking cessation while enrolled in the study (with the exception of the sc quitline). exclusion criteria 1. participants who are dependent on substances other than nicotine. 2. women who are pregnant during the clinical assessment session or either of the fmri sessions. these participants must agree to notify the study staff if they become pregnant during the study.